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clinical trial

FDA Gives Green Light for Multiple Sclerosis Stem Cell Trial

[Hope Biosciences Stem Cell Research Foundation (BusinessWire, Inc.)] Non-profit research organization Hope Biosciences Stem Cell Research Foundation has received FDA authorization for a randomized, double-blind, single center, Phase II clinical trial to assess the efficacy of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells in improving symptoms and quality of life in patients with mild-to-moderate multiple sclerosis.

Palisade Bio and Newsoara Announce Positive Topline Efficacy Results from Phase II Study of LB1148 Demonstrating Accelerated Return of Bowel Function after Gastrointestinal Surgery

[Palisade Bio, Inc.] Palisade Bio, Inc. and co-development partner Newsoara announced positive topline Phase II clinical trial data that LB1148 had a statistically significant effect in accelerating the return of bowel function in patients undergoing elective bowel resection surgery.

Stemson Therapeutics Secures $15M Series a Funding to Cure Hair Loss

[Stemson Therapeutics] Stemson Therapeutics announced the closing of a $15 million Series A financing to advance development of Stemson’s proprietary therapeutic solution to cure hair loss. Stemson’s iPSC based technology is capable of producing the cell types required to initiate hair follicle growth and have been successfully tested in small animal models.

Kronos Bio Announces FDA Clearance of Investigational New Drug Application for Lanraplenib (LANRA) for Treatment of Patients with Acute Myeloid Leukemia (AML)

[Kronos Bio, Inc.] Kronos Bio, Inc. announced the US FDA has cleared its Investigational New Drug Application for LANRA, allowing the company to proceed with a Phase I/II clinical trial of LANRA in patients with relapsed or refractory FLT3-mutated AML in combination with gilteritinib.

Decrease Post-Transplant Relapse Using Donor-Derived Expanded NK-Cells

[Leukemia] In this Phase I/II clinical trial, the authors investigated the safety and efficacy of high doses of mb-IL21 ex vivo expanded donor-derived NK cells to decrease relapse in 25 patients with myeloid malignancies receiving haploidentical stem-cell transplantation.

PolarityTE Submits Investigational New Drug Application for SkinTE® in Chronic Cutaneous Ulcers

[PolarityTE, Inc.] PolarityTE, Inc. announced the submission of an investigational new drug application to the US FDA seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.

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